MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during the procedure, when the subject coil was unable to detach.It was pulled and it stretched.The physician attempted to remove the subject coil using a snare but it prematurely detached.However, it was successfully removed from the patient anatomy.During this event, the superior mesenteric artery was partially injured and an unknown stent graft was used as treatment.The physician completed the procedure successfully.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported event.
Event or Problem Description
It was reported that during the procedure, when the subject coil was unable to detach.It was pulled and it stretched.The physician attempted to remove the subject coil using a snare but it prematurely detached.However, it was successfully removed from the patient anatomy.During this event, the superior mesenteric artery was partially injured and an unknown stent graft was used as treatment.The physician completed the procedure successfully.

• Brand Name: TARGET XXL 360 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10584289
• Report Number: 3008881809-2020-00275
• Device Sequence Number: 2822360
• Product Code: HCG
• UDI-Device Identifier: 07613327128307
• UDI-Public: 07613327128307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: M0036181240
• Device Catalogue Number: M0036181240
• Device Lot Number: 22137161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INZONE DETACHMENT SYSTEM (STRYKER); STENT (UNKNOWN); INZONE DETACHMENT SYSTEM (STRYKER); STENT (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention